Effectiveness and Safety Study of the DexComâ„¢ G4 Continuous Glucose Monitoring System in Children and Adolescents With Type 1 Diabetes Mellitus
| Status: | Archived |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | August 2010 |
| End Date: | November 2010 |
The purpose of this study is to evaluate the safety and effectiveness of the G4 System when
worn for up to 7-days by children and adolescent subjects (6 to <18 years-old) with type 1
diabetes mellitus.
Device performance will be primarily evaluated in terms of the proportion of G4 System
values that are within ±20% of the study meter reference value for glucose levels >80 mg/dL
and ±20 mg/dL at meter glucose levels <80 mg/dL. This proportion will be compared to the
proportion of such points observed in the DexCom clinical study that will be used to apply
for FDA approval of the G4 System (PTL 900360) for adults.
Safety data of the G4 System will also be collected and safety will be characterized by the
incidence of Adverse Device Effects, Serious Adverse Device Events, and Unanticipated
Adverse Device Effects experienced by study participants.
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